Methods and apparatus for coagulating and/or constricting hollow anatomical structures

ABSTRACT

An energy delivering probe is used for thermally coagulating and/or constricting hollow anatomical structures (HAS) including, but not limited to, blood vessels such as perforator veins. The probe includes a shaft and at least two electrodes where at least one of the electrodes has a generally spherical or toroidal geometry.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to medical methods andapparatus. More particularly, the present invention relates to thedesign and use of energy delivering probes for thermally coagulatingand/or constricting hollow anatomical structures (HAS) including bloodvessels such as the perforator veins which connect the superficial veinsto the deep veins in the leg, truncal superficial veins of the leg(e.g., great saphenous vein, short saphenous vein, and the like),superficial tributary veins of the leg, internal spermatic veins(varicoceles), ovarian veins, gonadal veins, hemorrhoidal vessels,fallopian tubes, a-v malformations, a-v fistula side branches,esophageal varices, and the like. For purposes of illustration,apparatus and methods of the present invention for use in treatingperforator veins will typically be described.

Perforator veins connect the deep venous system of a leg to the surfaceveins which lie closer to the skin. Normal or healthy perforator veinspass blood from the surface veins to the deep veins as part of thenormal blood circulation. Incompetent perforator veins allow blood flowfrom the deep venous system to the surface veins, causing orcontributing to problems, such as varicose veins, edema, skin and softtissue changes, lipodermatosclerosis, chronic cellulites, venous ulcers,and the like.

Several procedures have been proposed for interruption of incompetentperforator veins. The “Linton” procedure requires a very long incision(knee to ankle) on the medial calf to expose the perforator veins.Individual veins may then be surgically dissected, ligated, and cut toprevent blood flow between the superficial and deep venous systems. Aless invasive alternative has been developed by DePalma where individualincompetent perforator veins are identified along “Linton's Line” usingultrasound. Small incisions are then used to access the individualperforators for ligation and dissection. More recently, individualligation and dissection of perforator veins has been performed using anendoscope inserted in the proximal calf.

Although generally effective, each of the above-described proceduresrequires surgical incisions followed by ligation and cutting of theveins. Thus, even at best, the procedures are traumatic to the patientand require significant surgical time. Moreover, the procedures arecomplex and often require a second surgeon to assist in the procedure.

For these reasons, it would be desirable to provide additional andimproved techniques for disrupting incompetent perforator veins for thetreatment of varicose veins, edema, skin and soft tissue changes,lipodermatosclerosis, chronic cellulites, venous ulcers, venous ulcers,and other conditions. Such procedures should preferably be minimallyinvasive, e.g., relying on an introducer sheath, cannula, catheter,trocar, or needle for gaining access to the perforator veins at the deepfascial plane. In particular, it would be desirable if the methodsrequired few or no incisions, could be performed under a localanesthetic, would reduce post-operative healing time, as well asmorbidity and complication rates, and would require only a singlesurgeon. In addition, it would be desirable to provide apparatus andmethods which are useful for performing procedures on other tissues andhollow anatomical structures in addition to perforator veins. At leastsome of these objectives will be met by the inventions described hereinbelow.

2. Description of the Background Art

The following U.S. patents and published applications describeradiofrequency (RF) probes having expandable electrode structures fortreating incompetent venous valves and are commonly assigned with thepresent application: U.S. Pat. Nos. 6,401,719; 6,258,084; 6,237,606;6,179,832; US2002/0148476; and US2001/0041888, the full disclosures ofwhich are incorporated herein by reference. Probes as described in thesepatents have been used to treat refluxing veins, including perforatingveins, as described in Whiteley et al. (2003) Venous Forum Abstracts,Phlebology 18:1. Other patents directed at treating veins withradiofrequency energy include U.S. Pat. Nos. 5,437,664 ; 3,301,258; andU.S. Pat. No. 3,733,99. The Cameron-Miller 80-8010 Coagulator intendedfor destroying tortuous tributaries and other varicosities is describedin a brochure entitled An Exceptionally Successful Way to TreatVaricosities, published by Cameron-Miller, Inc., Chicago, Ill. (undated,but available prior to the invention herein). Radiofrequency probes withspaced-apart rings and other electrodes are described in U.S. Pat. Nos.6,391,026; 6,332,880; 5,734,903; and 4,966,597. A radiofrequency probewith a ball electrode is described in U.S. Pat. No. 5,897,553. Otherpatents and published applications relating to radiofrequency probes andapparatus include: U.S. Pat. Nos. 6,669,672; 6,587,731; 6,539,265;6,480,746; U.S. Pat. Nos. 6,346,102; 6,283,961; 6,267,758; 6,090,104;6,077,261; 6,042,590; 6,041,679; 6,030,382; 5,976,131; 5,925,045;5,893,849; 5,810,802; 5,766,167; 5,752,951; 5,709,224; 5,658,282;5,643,257; 5,562,703; 5,556,396; 5,334,193; 5,281,216; 5,281,218;5,122,137; 4,832,051; 4,765,331; 4,643,186; 4,548,207; 4,532,924;4,481,953; 3,920,021; 3,230,957; 3,100,489; 2,022,065; 1,943,543;8,337,59; US2002/0143325; and WO98/09575. Medical publications ofinterest include; O'Reilly, Kevin, Endovenous Diathermy Sclerosis as aUnit of The Armamentarium for the Attack on Varicose Veins; The MedicalJournal of Australia, Jun. 1, 1974, p. 900; Watts, G. T., EndovenousDiathermy Destruction of Internal Saphenous; British Medical Journal,Oct. 7, 1972, p. 53; O'Reilly, Kevin, Endovenous Diathermy Sclerosis ofVaricose Veins; The Australian, New Zealand Journal of Surgery, Vol. 47,No. 3, June 1977, pP. 339-395; O'Reilly, Kevin, A Technique of DiathermySclerosis of Varicose Veins; The Australian, New Zealand Journal ofSurgery, Vol. 51, No. 4, August 1981, pP. 379-382; Cragg et al.,Endovascular Diathermic Vessel Occlusion; Diagnostic Radiology, 144:303-308, July 1982; Ogawa et al., Electrothrombosis as a Treatment ofCirsoid Angioma in the Face and Scalp and Varicosis of the Leg; Plasticand Reconstructive Surgery, Vol. 3, September 1982, pP. 310-311;Brunelle, et al., A Bipolar Electrode for Vascular Electrocoagulationwith Alternating Current; Radiology, October 1980, Vol. 137, pP.239-240; Aaron, Electrofulguration for Varicose Veins; The MedicalLetter on Drugs and Therapeutics, Jul. 12, 1968, Vol. 10, No. 14, Issue248, p. 54; and Corbett, Phlebology 17:36-40 (2002).

The following patents and pending applications are assigned to theAssignee of the present application and are generally related to theradiofrequency energy treatment of veins: U.S. Pat. Nos. 6,752,803;6,689,126; 6,682,526; 6,638,273; 6,613,045; 6,322,559; 6,398,780;6,263,248; 6,200,312; 6,165,172; 6,152,899; 6,139,527;6,135,997;6,071,277; 6,036,687; 6,033,398; 6,014,589; 6,003,397; and U.S. Ser.Nos. 10/775,841; 10/738,488; 10/568,593; U.S. Pat. Nos. 7,041,098;6,752,803; 6,769,433; 6,969,388; and 6,981,972. The full disclosures ofeach of thesepatents and pending application are incorporated herein byreference.

BRIEF SUMMARY OF THE INVENTION

The present invention provides both apparatus and methods forcoagulating and/or constricting a hollow anatomical structure (HAS) inorder to inhibit or stop fluid flow therethrough. By “constricting,” itis meant that a portion of the lumen of the treated HAS is reduced insize so that fluid flow therethrough is either reduced or stoppedentirely. Usually, constriction will result from endothelial denudation,a combination of edema and swelling associated with cellular thermalinjury, and denaturation and contraction of the collagenous tissuesleading to a fibrotic occlusion of the HAS so that fluid flow is reducedor stopped entirely. In other cases, constriction could result fromdirect fusion or welding of the walls together, typically when pressureand/or energy are applied externally to the HAS. In either case, someportions of the lumen may remain open allowing fluid flow at a greatlyreduced rate. The constriction may thus occur as a result of contractionof the collagenous tissue in the HAS, or may alternately occur as aresult of direct fusion or welding of the walls together induced byheating of that tissue and/or surrounding tissue. Such heating may occuras a result of the application of energy directly to the walls of theHAS and/or to the tissue surrounding the HAS. Although the inventionwill describe delivering RF energy from the electrode(s) it isunderstood that other forms of energy such as microwave, ultrasound,lower frequency electrical energy, direct current, circulating heatedfluid, fiber optics with radiant light and lasers, as well as thermalenergy generated from a resistive coil or curie point element may beused as well. In the case of RF energy, the energy will typically beapplied at a power level in the range from 0.1 W to 300 W, typically ata frequency in the range from 100 KHz to 1 MHz and for a time in therange from 1 second to 5 minutes, although for longer regions, thetreatment time could be 10 minutes or longer.

While the apparatus and methods of the present invention will beparticularly suitable for constricting incompetent perforator veins forthe treatment of varicose veins, venous ulcers, or the like, they willalso be suitable for treating other venous structures, such as thesaphenous veins for the treatment of venous reflux, and otherconditions. In other cases, the apparatus and methods may be suitablefor treatment of arterial and other hollow anatomical structures aswell.

The methods of the present invention may be performed with a widevariety of apparatus which are adapted to position electrode structuresadjacent to or within the HAS to be constricted, typically a perforatorvein at a location beneath the fascial layer. The apparatus willgenerally include a shaft having the electrode structure at or near itsdistal end. The electrode structure may comprise one or moreelectrode(s) energized at a common polarity for use in “monopolar”protocols. Alternatively the electrode structure may comprise at leasttwo electrically isolated electrodes for performing bipolar protocols.The electrode shaft may be rigid, flexible, or have regions of varyingrigidity and/or flexibility. Often, the apparatus shaft will be used incombination with an introducer sheath, cannula, or catheter where theshaft will be introduced through a lumen thereof. For example, theapparatus may be introduced through the working channel of an endoscopewhich acts as a delivery sheath or cannula. Alternatively oradditionally, the shaft itself may comprise one or more lumens, and suchlumen(s) may be adapted to receive a needle or trocar to facilitatedirect or “self-penetrating” introduction of the shaft or to advance theshaft over a guidewire through tissue to the target treatment site. As athird alternative, the shaft may have an integral or fixed sharpeneddistal tip in order to allow direct or “self-penetrating” introductionof the shaft through tissue to the target treatment site. The latter twoapproaches will generally require that at least a portion of the shaftbe rigid in order to allow for pushability, but it would also bepossible to provide for temporary placement of a rod or other stiffeningelement within or around an otherwise flexible shaft while it is beingforwardly advanced through tissue to the target treatment site.

Thus, the apparatus of the present invention may be introduced to thetarget treatment site in a variety of ways, including direct or“self-penetrating” introduction where the shaft has a sharpened distaltip, either permanently affixed or removably placed in a lumen of theshaft, e.g. using a needle or trocar. Alternatively, the shaft carryingthe electrodes may be introduced through the lumen of a separateintroducer sheath, cannula, or catheter which has been previouslyintroduced using conventional techniques. Third, the shaft can beintroduced over a guidewire which has been previously introduced,typically using a needle for conventional guidewire placement. Otherintroduction protocols, including combinations of the three justdescribed, may also be used. Furthermore, endoscopic introduction aswell as endoscopically guided introduction of the apparatus may also beused.

The treatment protocols of the present invention may rely onendovascular treatment, extravascular treatment, or combinationsthereof. By “endovascular,” it is meant that one or more of thetreatment electrodes will be introduced into the lumen of the HAS beingconstricted. The electrodes may be introduced and left at a treatmentlocation immediately adjacent to the entry penetration through the HASwall. Alternatively, particularly when using flexible shafts andguidewires, the electrodes may be advanced intraluminally to a treatmentlocation spaced some distance from the entry penetration through the HASwall. By “extravascular,” it is meant that the treatment electrodes areplaced adjacent or near to the outside wall of the HAS being treated.More simply, the electrode structure may be introduced to such alocation outside of the HAS wall, and the treatment initiated bydelivering the treatment energy. Alternatively, the electrodes may bepinned on the side of the HAS wall using a sharpened tip or trocarassociated with the apparatus shaft. The combinations of theseapproaches may also be used, for example where a first electrode ispassed to a posterior side of the HAS while a second electrode remainson the anterior side.

In a first aspect of the present invention, a bipolar electrode probecomprises a shaft having a proximal end and a distal end, a generallyspherical or toroidal first electrode disposed near the distal end ofthe shaft, a second electrode spaced axially from the first electrode,and an electrical connector near the proximal end of the shaft forconnecting the first and second electrodes to opposite poles of anelectrosurgical power supply. By generally “spherical or toroidal,” itis meant that the electrode will have an outer, exposed surface whichprotrudes radially from a cylindrical wall or section of the shaft. Theouter surface will usually be axially symmetrical and will be curved ina plane passing axially through the shaft. The curve will preferably besmooth, but will not necessarily have a constant radius. The radius willusually vary with a range from 0.5 to 10 times the shaft diameter.

In the preferred embodiments, the bipolar electrode probes will includeonly first and second electrodes. There will be no additional electrodesspaced axially from the first and second electrodes. In some cases,however, it may be desirable to form either the first or secondelectrodes in multiple segments arranged either axially orcircumferentially, but such segments will always be commonly connectedto a pole of the power supply and will be intended to act together as asingle electrode surface.

In other specific embodiments, the second electrode structure will alsobe a generally spherical or toroidal electrode. In cases where both thefirst and second electrodes are spherical or toroidal, the more proximalof the two electrodes may have a less curved surface than the moredistal of the electrodes. In some cases, the more proximal electrode mayhave a generally tapered, curved surface which becomes smaller in thedistal direction. In other cases, the more distal electrode may have ataper in the distal direction providing an entry angle and transition tothe electrode to ease advancing of the probe through tissue and/orthrough the wall of a hallow anatomical structure.

The spherical or toroidal electrodes will have a diameter in a rangefrom 1 mm to 5 mm, preferably from 1 mm to 3 mm, typically being about 2mm. The particular diameter chosen will depend on the selected method ofaccess, where smaller diameter electrodes will require smaller accessholes or incisions. The electrodes will be spaced-apart axially by adistance in the range from about 1 mm to 5 mm, preferably by about 1.5mm (measured axially from inner edge to inner edge).

The shaft may be flexible or rigid and will preferably have at least asingle central lumen extending from the proximal end to the distal end.The bipolar electrode structure may further comprise a trocar having asharpened distal end disposed in one of the central or other lumens ofthe shaft so that the sharpened end extends distally beyond the shaft,typically by distance in the range from 1 mm to 10 mm. The trocar willpreferably be removable, although in other embodiments described below,a trocar may be fixed to the shaft and define a distal-most electrodesurface. In all cases, the trocar can be solid or flexible, but willpreferably have an axial lumen to optionally permit introduction over aguidewire or delivery of fluid to the treatment site.

The trocar lumen can also provide for blood “flashback” indicating whenthe trocar has entered the HAS being treated.

In embodiments intended for direct introduction through tissue with atrocar or other sharpened distal tip, the shaft and/or the trocar willpreferably be rigid to facilitate advancement. In other cases, where theelectrode probe is intended for introduction over a guidewire, the shaftwill usually be flexible. In the case of such flexible shafts, a slidingexternal sheath or cannula may be provided over the exterior in order toenhance stiffness to assist in insertion. Alternatively, in the case offlexible shaft devices, an internal stiffening member may be provided.Said stiffening member may be comprised of polymeric materials includingPEEK, metals including stainless steel, composite structures includingbraided polyimide, and the like.

In a specific embodiment, the bipolar probe has a sharpened distal endthat extends distally from the first electrode. The sharpened distal endmay be formed as a trocar received within a central lumen of the shaft,usually being fixed in the shaft but optionally being removable andreplaceable. Alternatively, the sharpened distal tip may be formed as aseparate component and attached at the distal end of the shaft. Thesharpened distal end is preferably electrically active and defines atleast a portion of the electrode, preferably being formed as acylindrical tube having a diameter in the range from about 0.5 mm toabout 1 mm, and a length in the range from about 1.5 mm to 5 mm. Theproximal end of the sharpened distal electrode and the distal end of thefirst electrode will preferably be spaced-apart by a distance in therange from 1 mm to 5 mm, preferably by about 1.5 mm. In some cases, thespace between the electrode may be tapered in the distal directionproviding an entry angle and transition to the electrode to easeadvancing of the probe through tissue and/or through the wall of ahallow anatomical structure. The shaft will preferably have a lumentherethrough, including through the sharpened distal end, in order topermit the detection of flashback upon HAS entry, optional introductionover a guidewire and/or the delivery of saline or other fluids during aprocedure.

In all of the above embodiments, at least one temperature sensor may bedisposed on the probe, typically being on or near one or more of theelectrodes. In the specific examples, at least one temperature sensormay be placed on a spherical or toroidal electrode. The temperaturesensors will be suitable for connection to the external power supply toallow for monitoring and optional control of the temperature during thetreatment.

In a second aspect of the present invention, a method for constricting atarget HAS comprises percutaneously introducing a distal end of a probeto a location near the HAS and delivering energy into the target HAS toconstrict the target region of the HAS. The probe may be introduced byadvancing a sharpened distal end thereof through tissue directly to thetarget region, by positioning a sheath through tissue to the targetregion and advancing the probe through the sheath, or by positioning aguidewire through a needle, removing the needle, and advancing the probeover the guidewire to the location near the target HAS. Othercombinations of these approaches may also be possible.

In some cases, it will be preferable to image the target location, suchas the HAS and surrounding tissue while the probe is being introduced.Usually, color duplex or other ultrasonic imaging will be sufficient,although other imaging, such as fluoroscopic, would be possible. As athird alternative, the target location may be endoscopically viewedwhile the probe is being introduced, e.g., through a working channel ofan endoscope.

The electrodes may be positioned in a variety of relationships to theHAS being treated. For example, the electrodes may be positionedextravascularly, typically on one side of the HAS, usually within 4 mmand preferably directly adjacent to the exterior of the HAS wall, whileenergy is being delivered. Alternatively, one or both electrodes may bepositioned endovascularly where the electrode(s) are located within alumen of the HAS when energy is delivered.

In a specific embodiment, an electrode having a sharpened end ispenetrated through the HAS while an exterior surface of the HAS isengaged by a spherical or toroidal electrode on the probe. The HAS maybe collapsed by pressure from the spherical or toroidal electrode sothat the simultaneous application of pressure and heat will causeconstriction of the HAS.

In other alternative protocols, either or both of the electrodes,preferably spherical or toroidal electrodes, may be passed entirelythrough the target HAS and thereafter drawn backwardly against the HASwall and optionally through the HAS wall while applying energy.

In preferred aspects of the present invention, the temperature will bemonitored near at least one of the electrodes, allowing monitoringand/or control of the HAS constriction. For example, the radiofrequencyenergy may be delivered at from 0.1 W to 300 W to obtain a monitoredtemperature in the range from 70° C. to 100° C. for a time sufficient toachieve HAS constriction.

In further preferred aspects of the method of the present invention,saline or other physiologically acceptable fluid will be delivered tothe region being treated while the radiofrequency energy is beingdelivered. Preferably, the fluid will be delivered through a lumen inthe probe itself.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a system constructed in accordance with theprinciples of the present invention including a probe and aradiofrequency electrosurgical power supply.

FIG. 2 illustrates a first exemplary distal tip of a probe constructedin accordance with the principles of the present invention.

FIG. 3 illustrates the probe tip of FIG. 2, shown with an introducertrocar removed.

FIG. 4 illustrates a second exemplary probe constructed in accordancewith the principles of the present invention, comprising a flexibleshaft.

FIGS. 5 and 5A are schematic illustrations illustrating the dimensionsof a first probe-tip construction according to the principles of thepresent invention.

FIG. 6 illustrates a third exemplary probe constructed in accordancewith the principles of the present invention.

FIGS. 7, 7A, and 7B are schematic illustrations of alternate embodimentsof the tip of the probe of FIG. 6 marked to show dimensions.

FIGS. 8A-8D illustrate use of the probe illustrated in FIG. 1 inperforming a procedure according to the method of the present invention.

FIGS. 9A-9C illustrate the probe of FIG. 1 in performing a secondexemplary procedure in accordance with the principles of the presentinvention.

FIGS. 10A-10E illustrate the use of the probe of FIG. 1 for performing athird exemplary procedure according to the principles of the presentinvention.

FIGS. 11A-11B illustrate the use of the probe of FIG. 6 for performing afourth exemplary procedure according to the present invention.

FIGS. 12A-12D illustrate the use of a trocar with a rigid probe having apair of spaced-apart electrodes for endovascular treatment of a HAS inorder to constrict the HAS in accordance with the principles of thepresent invention.

FIGS. 13A-13C illustrate the use of a rigid probe having a singleelectrode for penetrating and pinning a HAS in order to constrict theHAS in accordance with the principles of the present invention.

FIGS. 14A-14D illustrate the use of a flexible probe introduced througha percutaneous sheath performing an endovascular treatment of a HAS inorder to constrict the HAS in accordance with the principles of thepresent invention.

FIGS. 15A-15F illustrate the use of a small gage needle for placement ofa guidewire and introduction of a two electrode probe with slidingexternal sheath over the guidewire in order to constrict the HAS inaccordance with the principles of the present invention.

FIGS. 16A and 16B illustrate a particular method for introducing a twoelectrode probe to the fascial layer and moving the probe until thedefect in the fascial layer is detected and the probe is introducedthrough the defect to a location adjacent to a HAS in order to constrictthe HAS in accordance with the principles of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Referring to FIG. 1, a first exemplary system 10 constructed inaccordance with the principles of the present invention comprises abipolar electrode probe 12 and a radiofrequency (RF) electrosurgicalpower supply 14. A bipolar electrode probe 12 comprises a flexible shaft16 having a distal end 18 and a proximal end 20 having a Y-shapedconnector hub 22 attached thereto. A first electrode 24 and secondelectrode 26 are mounted on the shaft 16 near the distal end 18. Theshaft 16 has a central lumen which extends over its entire length (fromthe proximal end to the distal tip), and the lumen may be connected,typically via a luer connector (now shown) through a flexible line 30having a luer or other connector hub 32 at its other end which can beconnected to a source of infusion fluid, typically saline. Theelectrodes 24 and 26 may be connected to the radiofrequencyelectrosurgical power supply 14 through a cable 34 and connector 36. Theconnections to the electrodes 24 and 26 are isolated so that the twoelectrodes may be connected to opposite poles of the power supply 14, inthe case of a bipolar configuration.

Optionally, an external sheath 38, typically in the form of a rigidmetal or other cannula, is slidably received over the exterior of theflexible shaft 16. The sheath provides external stiffening of theflexible shaft 16 when desired. The sheath may include a handle or grip40 near a proximal end thereof to facilitate its manipulation.Additionally, the sheath 38 may be sharpened at its distal end to allowfor improved tissue penetration.

The external sheath 38 may allow selective stiffening of an otherwiseflexible shaft 16. Typically, during access, the sheath 38 will beplaced in a forwardly advanced position to provide a rigid structurewhich is more controllable during subcutaneous manipulation andadvancement over a guidewire or through a cannula where flexibility isnot required and can even be a disadvantage. After positioning a distalend 18 of the shaft 16 at the desired treatment location, the externalsheath 38 can be partially or fully withdrawn to expose a distal lengthof the flexible shaft 16 to allow further advancement into the HAS or tosimply remove the rigid structure during treatment or while externalcompression is used to manipulate the device tip into contact with theHAS wall.

The first and second electrodes 24 and 26 are illustrated as generallyspherical or toroidal electrodes, as defined above. The flexible body16, which is typically formed from a polymer or other electricallyinsulating material, acts to isolate the electrodes and provide thedesired axial spacing, also as discussed above. While the electrodes areillustrated as spherical or toroidal, a variety of other specificdesigns may used under different circumstances, as will be discussedbelow.

Referring now to FIGS. 2 and 3, a first specific electrode designcomprising a first electrode 44 in the form of a ring which is typicallytoroidal with a very flat surface and a second electrode 46 which isgenerally spherical or toroidal, as defined above. The first and secondelectrodes are disposed at the distal end of a polymeric shaft or body48, in a variety of ways. For the flexible shaft embodiment of FIGS. 1through 3, as well as 4 discussed below, they can be attached throughthe center lumen of the shaft. Other embodiments are described below.

A trocar or needle 50 is received in the central lumen of the body 48.The trocar 50 has a sharpened distal end or tip 52 so that it may beintroduced directly into solid tissue, for example for accessing a HASin the procedures described below. Electrodes 44 and 46 are spaced-apartby a spacer 54 located therebetween and isolated by a polymeric tube(not shown) insulating the entire length under the proximal electrode44. The trocar is preferably removable, leaving the structureillustrated in FIG. 3. At least one temperature sensor, typically athermocouple or a thermistor 56, will be provided on or near either ofthe electrodes. As illustrated, it is at the proximal end of the firstelectrode 44. The temperature sensor is connected to the power supplythrough wires 58. The first and second electrodes are connected to apower supply through isolated wires 60 and 62. In other embodiments, theelectrode(s) may run the entire length of the device, thus eliminatingthe need for separate connecting wires.

Usually, at least one of the probe body or shaft 48 and the trocar 50will be rigid to facilitate advancement of the sharpened tip of trocar50 through tissue. Usually, at least the trocar will be rigid since itwill most often be composed of stainless steel or another metal. Often,the probe body 48 will also be rigid or stiffened by reinforcingelements.

The trocar 50 may have an internal lumen and a port or opening 64 at itsdistal end, typically to permit the detection of flashback upon HASentry, optional introduction over a guidewire and/or the delivery ofsaline or other physiologically acceptable fluid to the treatment regionduring a procedure.

Construction of a particular embodiment of the electrosurgical probe 12of FIG. 1 is shown in more detail in FIG. 4. The flexible body or shaft16 has lumen 70 shown in a broken-away portion thereof. The lumen 70carries a tube 72 which is connected to the second electrode 26. Aninsulating region 74 is provided between the second electrode 26 and thefirst electrode 24, and a wire 78 is connected to the second electrodeand runs proximally through the probe and to the electrical connector36. A second wire (not shown) is connected to the first electrode 24 andalso runs proximally to the connector 36. Similarly, temperature sensorwires are connected to the thermocouple, thermistor, or otherthermosensor 80 and run through the flexible body 16 to the connector36. The inner shaft 72 is preferably formed from a structurallyreinforced material such as braided polyimide, while the outer shaft maybe formed from a polymeric extrusion such as thermoplastic polyesterelastomers, polyimide, nylons, PEEK, polyether-block co-polyamidepolymers, and the like. The connecting tube 30 may be formed frompolyvinylchloride (PVC) or other suitable polymer and have a luerfitting 32 at both free ends. Tube 30 may be connected to the hub 22byaluer 31.

Referring now to FIG. 5, exemplary dimensions for the embodiments of thepresent invention which employ pairs of spherical or toroidal electrodeswill be described. These spherical or toroidal electrodes will typicallyhave a diameter D in a plane which is transversed to the axis of thecatheter body in the range from 1 mm to 3 mm. The flexible probe bodywill have a diameter d which is smaller than that of the electrodes,typically being in the range from 0.5 mm to 2.5 mm. The distance lbetween the inner edges of the spherical electrodes will be in the rangefrom 1 mm to 5 mm. As shown in FIG. 5A, the distal electrode may have ataper in the distal direction providing an entry angle β to theelectrode improving the ability to advance the probe through tissueand/or through the wall of an HAS. The entry angle β of the spherical ortoroidal electrode will be in the range from 0° to 90°, typically beingin the range from 0° to 60°.

Referring now to FIG. 6, a third embodiment of a bipolar electrode probe90 constructed in accordance with the principles of the presentinvention is illustrated. Proximal portions of probe body 92 will be thesame as for previously described embodiments. Probe body 92 may be rigidor flexible and will, as with prior embodiments, have a lumentherethrough. Within the lumen, a trocar 94 having a sharpened tip 96will be removably received within the lumen. A first spherical ortoroidal electrode 98 is integral or attached to the distal end of theprobe body 92. The trocar 94 acts as the second electrode, and isinsulated from the remaining components by a sleeve 100. The sleeve 100may run the entire length of the device to provide insulation. The firstelectrode 98 may also run the entire length over the sleeve 100 andwithin the probe body 92 to provide for electrical connection back to aproximal hub (not shown). A thermocouple 104 or other temperature sensormay be connected through wires (not shown) which run the length of theprobe. The apparatus of FIG. 6 can provide for the introduction ofsaline or other physiologically acceptable fluid through a multi-arm hub(not shown). The fluid can be delivered through the lumen runningthrough the trocar 94 and/or through an annular space between the outersurface of sleeve 100 and the inner surface of the electrode 98.

Typical dimensions for the distal probe end of FIG. 6 are shown in FIG.7. The exposed portion of trocar 94 has a length l₁ in the range from 1mm to 10 mm, and a diameter d in the range from 0.5 mm to 1 mm. Theproximal most end of the exposed trocar 94 is spaced apart from aspherical or toroidal electrode 108 by a distance l₂ in the range from 1mm to 5 mm. The diameter D of the spherical or toroidal electrode isgenerally the same as described above, typically being in the range from1 mm to 3 mm. As shown in FIG. 7A, the generally spherical or toroidalelectrode may have a taper in the distal direction providing an entryangle β to the electrode improving the ability to advance the probethrough tissue and/or through the wall of an HAS. The entry angle β isgenerally the same as described above being in the range from 0° to 90°,typically being in the range from 0° to 60°. Optionally, as shown inFIG. 7B, the space between the electrodes may be tapered in the distaldirection providing an entry angle β and transition element 95 improvingthe ability to advance the probe through tissue and/or through the wallof an HAS. The entry angle β is generally the same as described abovebeing in the range from 0° to 90°, typically being in the range from 0°to 60°.

Referring now to FIGS. 8A-8D, use of the probe of the present inventionfor performing constriction of a perforator vein P or other HAS isillustrated. While the use is described in connection with the rigidbipolar electrode probe 12, the method will generally apply to the otherembodiments described herein. The perforator vein connects the deepvenous system DV to the superficial venous system SV, as generally shownin each of the figures. Access to the perforator vein P or other HAS maybe achieved with a conventional needle and cannula assembly 110, asillustrated. Alternatively, direct access may be achieved relying on theexposed trocar tip 52 or 96 (FIG. 2 or 6). As illustrated in FIGS.8A-8D, cannula 110 is introduced through the skin to the target site,and a needle removed from the cannula, as shown in FIG. 8B. At thispoint, access to the interior of the perforator vein P or other HAS isprovided. The probe 12 may be introduced through the cannula to a sitewithin the perforator vein P or other HAS, as shown in FIG. 8C. Energymay then be applied through the electrodes 24 and 26 until a desireddegree of constriction has been achieved. In the exemplary embodiments,bipolar RF energy will heat the tissue and/or HAS, temperature willmonitored with a thermocouple on the probe, and the radiofrequencygenerator will modulate power to maintain the desired temperature. Aftera desired amount of treatment time, the treatment can be terminated andthe probe and cannula removed, leaving a constricted region CON in theperforator vein PV as shown in FIG. 8D.

The treatment protocol illustrated in FIGS. 8A-8D, is generally referredto herein as endovascular, i.e., within the HAS. While the use isdescribed in connection with the rigid bipolar electrode probe 12, themethod will generally apply to the other embodiments described herein.Radiofrequency probe 12 may also be used to perform extravasculartreatment, as illustrated in FIGS. 9A-9C. Access with the assembly 110may be achieved as generally described before, except that theperforator vein P or other HAS is not necessarily penetrated.Alternatively, direct access may be achieved relying on the exposedtrocar tip 52 or 96 (FIG. 2 or 6). As illustrated, the bipolar electrodeprobe 12 is introduced through the cannula 110 and the electrodes 24 and26 are positioned adjacent the exterior of the vein or other HAS. Theelectrodes are energized and the tissue heated sufficiently to constrictthe walls of the vein or other HAS, without any penetration, with theresulting constriction shown in FIG. 9C.

Referring now to FIGS. 10A-10E, a third protocol using the bipolarelectrode probe 12 for constricting the perforator vein P or other HASis illustrated. The needle and cannula 110 is introduced to fullypenetrate the perforator vein P or other HAS so that the tip passesthrough the far side. The needle is removed and bipolar electric probe12 introduced through a cannula, as shown generally in FIG. 10B. Asillustrated, the probe 12 is rigid but it could also have a flexibleshaft. While the use is described in connection with passing the probethrough a cannula, this method could alternatively be performed by“directly” penetrating the vein with a probe having a needle or trocarin a central lumen thereof as in FIG. 2 or having a sharpened distalelectrode being rigidly fixed to the probe as in FIG. 6. The electrodeson the probe 12 are then energized as the probe is drawn back to contactthe far side of the vein or other HAS, as shown in FIG. 10C. The vein orother HAS is heated and collapsed as the probe 12 is continued to bedrawn back through the HAS, as shown in FIG. 10D. Optionally, thecannula is completely removed by this point. As probe 12 is withdrawn,the perforator vein P or other HAS is constricted, as shown in FIG. 10E.

Referring now to FIGS. 11A and 11B, a fourth protocol of the bipolarelectrode probe 90 of FIG. 6 for treating a perforator vein P or otherHAS will be described. The probe 90 is introduced directly throughtissue under ultrasonic guidance until the sharpened tip 96 contacts theexterior of the vein or other HAS. The surgeon then advances thesharpened tip 96 through the vein or other HAS so that the spherical ortoroidal electrode 98 engages and collapses the vein or other HAS, asshown in FIG. 11B. The electrodes 94 and 98 are then energized to heatand constrict the walls of the vein or other HAS. As with all previousembodiments, the area may optionally be infused with saline or otherphysiologically acceptable fluid in order to enhance current flow,tissue heating, and HAS constriction. Hollow anatomical structure accessmay be confirmed by observation of flashback through a lumen of thesystem.

To this point, several devices and protocols for introducing rigid andnon-rigid probes through an introducer sheath, cannula, or catheter havebeen described. As shown in FIGS. 12A-12D, however, it is also possibleto introduce electrode structures on the exterior of a rigid ornon-rigid probe “directly”. Direct access is achieved using probe 120having a needle or trocar 122 in a central lumen thereof or having asharpened distal electrode being rigidly fixed to the probe as in FIG.6. The needle or trocar 122 has a sharpened distal tip 124 which allowsdirect penetration through the tissue until the sharpened tip 124reaches the perforator vein P or other HAS. The sharpened tip 124 isthen used to penetrate the HAS, as shown in FIG. 12B. The needle ortrocar 122 may then be retracted to within the probe 120, andradiofrequency energy delivered through the electrodes 126, as shown inFIG. 12C. The energy causes constriction CON of the perforator vein P orother HAS as shown in FIG. 12D. After the treatment is complete, theprobe 120 may be withdrawn. The protocol illustrated in FIGS. 12A-12Dcould also be performed using a single polarity and/or electrode device.Additionally, the protocol illustrated could also be used in performingan extravascular procedure.

Referring now to FIGS. 13A-13C, a rigid probe 140 having a sharpeneddistal tip 142 and a single electrode 144 may be introduced to directlyaccess the perforator vein P or other HAS, as shown in FIG. 13A, and topenetrate and pin the vein, as shown in FIG. 13B. Sufficient manualforce is maintained on the probe 140 to collapse the perforator vein Por other HAS while energy is being delivered, as shown in FIG. 13B. Theresult is a constriction CON in perforator vein P or other HAS when theprocedure is terminated, as shown in FIG. 13C. While the use isdescribed in connection with the rigid single polarity and/or electrodeprobe 140, the method will generally apply to the other embodimentsdescribed herein.

Referring now to FIGS. 14A-14D, use of a flexible instrument introducedthrough an introducer sheath, cannula, or catheter will be described. Aconventional needle and cannula assembly 160 having a removable needle162 may be introduced to a perforator vein P or other HAS underultrasound guidance. The cannula 160 may be introduced into theperforator vein P or other HAS using the needle 162, and the needlewithdrawn, as shown in FIG. 14B. A flexible probe 170 having a pair ofelectrodes 172 at its distal end may then be introduced through thecannula 160. The probe 170, with flexible and atraumatic tip, will alignitself with the interior of the perforator vein P or other HAS lumen, asshown in FIG. 14C. The length of the flexible probe allows for distaladvancement into the lumen after insertion. Energy is then deliveredthrough the electrodes 172 to constrict CON the vein or other HAS asshown in FIG. 14D. The probe 170 is then withdrawn into the cannula 160,and the assembly withdrawn.

Endovascular procedures may also be performed over a guidewire GWintroduced through an introducer sheath, cannula, or catheter 180 whichmay be introduced over a needle (not shown) in a conventional manner.Optionally, the guidewire GW may be introduced directly through theneedle. While the use is described in connection with a bipolarelectrode probe, the method will generally apply to the otherembodiments described herein. Referring now to FIGS. 15A-15F, the needle180 is introduced so that its distal end 182 enters the lumen of theperforator vein P or other HAS, as shown in FIG. 15B. The guidewire GWis then introduced through the needle 180, and the needle withdrawn, asshown in FIG. 15C, leaving the guidewire GW in place through the tissue,as shown in FIG. 15D. A combination flexible probe with rigid slidingexternal sheath 186 is then introduced over the guidewire GW, as shownin FIG. 15E. The sliding external sheath may be partially or fullyretracted to expose a distal length of the flexible probe to allow forfurther advancement into the HAS or to simply remove the rigid structureduring treatment (not shown). Radiofrequency energy is delivered throughthe electrodes 188 to constrict the perforator vein P or other HAS, asshown in FIG. 15F. The sheath and probe 186 may then be withdrawn. Asillustrated, the probe 186 has a flexible shaft, but it could also berigid.

To this point, the access protocols have all involved penetrating thetissue using a needle, cannula, trocar, or other penetrating instrument.Such penetration generally requires ultrasonic or other image guidancein order to properly locate the perforator vein or other HAS andinitiate treatment. As an alternative to this approach, as illustratedin FIGS. 16A and 16B, a probe 200 may be introduced through overlyingtissue until its distal tip 202 encounters the fascial layer F, as shownin FIG. 16A. Initially, as shown in broken line, the probe 200 willalmost certainly encounter a region of the fascia remote from the defectD through which the perforator vein P or other HAS passes. By properlymoving or “dottering” the tip 202 of the probe over the fascial layer,as shown in FIG. 16A, eventually the probe will encounter the defect andpass therethrough. Once the distal end of the probe has passed throughthe defect, the electrodes 204 will be properly positioned adjacent theextravascular wall of the perforator vein P or other HAS, as shown inFIG. 16B. Additional manipulation, such as conical rotation of the probe200, may allow the perforator vein P or other HAS to become wrappedaround the electrode portion of the probe 200. Another form ofmanipulation may include using the probe 200 as a lever to press theperforator vein P or other HAS against the fascial layer from below.Radiofrequency energy can then be delivered to constrict the HAS. Aswith all previous protocols, the probe 200 may then be withdrawn afterthe treatment is complete. As illustrated, the probe 200 has a rigidshaft, but it could also be a flexible or combination flexible probewith sliding external rigid sheath. Additionally, while the use isdescribed in connection with a bipolar electrode probe, the method willgenerally apply to the other embodiments described herein.

While the above is a complete description of the preferred embodimentsof the invention, various alternatives, modifications, and equivalentsmay be used. Therefore, the above description should not be taken aslimiting the scope of the invention which is defined by the appendedclaims.

1. A bipolar electrode probe comprising: an elongated shaft having anelongated axis, a proximal shaft end and a distal shaft end; a sharpeneddistal probe end; a rigid, generally spherical or toroidal firstelectrode disposed near the distal end of the shaft; a rigid secondelectrode spaced axially from the first electrode along the elongateaxis; and an electrical connector near the proximal end of the shaft forconnecting the first and second electrodes to opposite poles of anelectrosurgical power supply; wherein said second electrode is locateddistal of said first electrode along the elongate axis and said secondelectrode has a smaller radial profile than said first electrode suchthat the second electrode does not extend as far from the elongate axisas the first electrode; and wherein said probe is rigid and configuredto puncture body tissue with said sharpened distal probe end as saidsharpened distal probe end is urged against said body tissue.
 2. Abipolar electrode probe as in claim 1, including no additionalelectrodes spaced axially from the first and second electrodes.
 3. Abipolar electrode probe as in claim 1, wherein the second electrode is agenerally spherical or toroidal electrode.
 4. A bipolar electrode probeas in any one of claim 1, 2, or 3, wherein each electrode has a diameterin a transverse plane in the range from 1 mm to 5 mm.
 5. A bipolarelectrode probe as in claim 4, wherein the electrodes are spaced-apartby a distance in the range from 1 mm to 5 mm.
 6. A bipolar electrodeprobe as in any one of claim 1, 2, or 3, wherein at least one of theelectrodes comprises a proximal extension which conducts electricalenergy to an exposed electrode surface.
 7. A bipolar electrode probe asin any one of claim 1, 2, or 3, wherein the shaft has a central lumenextending from the proximal shaft end to the distal shaft end.
 8. Abipolar electrode probe as in claim 7, further comprising a trocarcomprising the sharpened distal probe end, the trocar disposed in thecentral lumen such that the sharpened end extends distally beyond theshaft.
 9. A bipolar electrode probe as in claim 8, wherein the trocarhas an axial lumen.
 10. The bipolar probe of claim 9, wherein saidtrocar further comprises a distal opening in communication with saidaxial lumen.
 11. A bipolar electrode probe as in claim 8, wherein thetrocar is removably received in the central lumen.
 12. The bipolar probeof claim 11, wherein said trocar extends proximally through said centrallumen beyond said first electrode.
 13. The bipolar probe of claim 7,wherein said shaft forms a distal tip opening in communication with saidcentral lumen.
 14. A bipolar electrode probe as in claim 8, wherein theprobe is rigid because at least one of the shaft and the trocar isrigid.
 15. A bipolar electrode probe as in any one of claim 1, 2, or 3,wherein the shaft is flexible.
 16. A bipolar electrode probe as in claim15, further comprising a rigid cannula slidably disposed over a portionof the length of the flexible shaft.
 17. A bipolar probe as in claim 1or 2, wherein the second electrode comprises the sharpened distal probeend and extends distally from the first electrode.
 18. A bipolar probeas in claim 17, wherein the first generally spherical or toroidalelectrode has a diameter in a transverse plane in the range from 1 mm to5 mm.
 19. A bipolar probe as in claim 18, wherein the second electrodeis a cylindrical tube having a diameter in the range from 0.5 mm to 1 mmand a length from 1 mm to 10 mm.
 20. A bipolar probe as in claim 19,wherein the first and second electrodes are spaced-apart by a distancein the range from 1 mm to 5 mm.
 21. A bipolar probe as in any one ofclaim 1, 2, or 3, having an axial lumen through the electrodes andshaft.
 22. A bipolar probe as in any one of claim 1, 2, or 3, whereinthe shaft is rigid.
 23. A bipolar probe as in any one of claim 1, 2, or3, further comprising a temperature sensor near the first or secondelectrode.
 24. A bipolar electrode probe comprising: a shaft having aproximal end and a distal end; a rigid, generally spherical or toroidalfirst electrode disposed near the distal end of the shaft; a rigidsecond electrode spaced axially from the first electrode; and asharpened tip configured to penetrate body tissue; wherein said probe isrigid so that said sharpened tip penetrates body tissue as saidsharpened tip is urged against said body tissue so that the probe canpass through the body tissue to a target treatment site; and whereinsaid second electrode is located distal of said first electrode and saidsecond electrode has a smaller maximum cross section, in a planeorthogonal to an axial direction of said probe, than does said firstelectrode.
 25. The bipolar electrode probe of claim 24, wherein thesecond electrode is a generally spherical or toroidal electrode.
 26. Thebipolar electrode probe of claim 25, wherein each generally spherical ortoroidal electrode has a diameter in a transverse plane in the rangefrom 1mm to 5 mm.
 27. The bipolar electrode probe of claim 25, whereinthe electrodes are spaced-apart by a distance in the range from 1 mm to5 mm.
 28. The bipolar electrode probe of claim 25, wherein the shaft hasa central lumen extending from the proximal end to the distal end. 29.The bipolar electrode probe of claim 28, further comprising a trocarcomprising the sharpened tip, the trocar disposed in the central lumensuch that the sharpened tip extends distally beyond the shaft.
 30. Thebipolar electrode probe of claim 29, wherein the trocar has an axiallumen.
 31. The bipolar electrode probe of claim 30, wherein said trocarfurther comprises a distal opening in communication with said axiallumen.
 32. The bipolar electrode probe of claim 29, wherein the trocaris removably received in the central lumen.
 33. The bipolar electrodeprobe of claim 29, wherein the probe is rigid because at least one ofthe shaft and the trocar is rigid.
 34. The bipolar electrode probe ofclaim 29, wherein said trocar extends proximally through said centrallumen beyond said first electrode.
 35. The bipolar electrode probe ofclaim 28, wherein said shaft forms a distal tip opening in communicationwith said central lumen.
 36. The bipolar electrode probe of claim 24,wherein the shaft is flexible.